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Marking pen linked to outbreak of diffuse lamellar keratitis in study
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Using a marking pen may contribute to the occurrence of diffuse lamellar keratitis after LASIK, according to a large study.
"However, the extensive investigations carried out by [marking pen manufacturer] Johnson & Johnson Medical did not reveal changes in the marking pens, which might have confirmed the marking pens as the cause of this sudden increase in DLK," the study authors said in the July issue of Journal of Cataract & Refractive Surgery.
Osmond Bruce Hadden, FRANZCO, and colleagues performed 522 consecutive LASIK procedures between Dec. 18, 2006, and Feb. 23, 2007, at Eye Institute in Auckland, New Zealand. The surgeons used a Codman surgical marking pen (Johnson & Johnson Medical) to ink the corneal realignment marker in 403 procedures; 119 procedures were performed without the marking pen.
"During the period, it was noted that the Codman surgical marking pens ... had been provided in different packaging from mid-December 2006," the authors said.
No eyes treated without the marking pen developed DLK; of those in which the marking pen was used, 49 (12.2%) developed DLK (P < .0001), according to the study.
After the DLK outbreak was identified, one surgeon performed five consecutive bilateral cases using the marking pen in right eyes only.
In these cases, four right eyes and no left eyes developed DLK (P = .03).
Overall, 45 of the 49 eyes with DLK recovered quickly; the other four developed central toxic keratopathy, the authors noted.
An investigation conducted by Johnson & Johnson Medical revealed that while the packaging of the marking pens had changed, the packaging location and sterilization process had remained the same. Furthermore, the company advised the study authors that the marking pen is also sold under a different brand name that has received no complaints about DLK, according to the study.